Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Sponsor
KK Women's and Children's Hospital
Study ID
NCT05081037
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Glucose Metabolism Disorders
  • Metabolic Disease

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Wearable Care Group — DEVICE
    Continous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels.

Study Details

This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years: 1. Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes. 2. The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range. 3. There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.

Key Dates

First listed
Oct 18, 2021
Start date
Sep 6, 2021
Status verified
Mar 2025
Primary completion
May 26, 2026
Completion
May 26, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Wearable Care Group
    This group will receive both a continous glucose monitoring sensor and an exercise tracker to be worn for at least 2 weeks at each study visit timepoint.
  • No Intervention: Scheduled Care Group
    This group will receive standard medical care with dietary and nutritional advice alone.

Primary Outcome Measure

Clinically diagnosed Type II Diabetes Mellitus [ Time Frame: At 6 months (23-26 weeks) from baseline visit ]

Central Contacts

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